Morphine Modulation of The Brain's Pain Matrix

NCT01245244 | Completed Phase 4 DMC

• 1 other identifier: 2010-020894-17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current project is to use a model of painful stimulation of skin, muscles and internal organs, where it is possible to measure activity in the brain centers that process pain simultaneously. Magnetic resonance imaging and electroencephalography are combined to optimize the anatomical and physiological description of brain activation. During administration of morphine we will identify how different brain areas are affected. This knowledge will be used to: 1\. Understand the mechanisms of morphine to a greater extent than is possible today, including:

1. 1.to investigate the mechanisms of morphine versus placebo on pain signals in the spinal cord and brain. This is done by a combination of experimental pain models, neurophysiological and imaging techniques (EEG and fMRI). This can be achieved as both subjective and objective measures of the analgesic effect.
2. 2.to examine morphines effect on communication between the centers of the brain that are involved in painprocessing .
3. 3.modeling of morphine pharmacokinetics (the understanding of what the body does to the drug, such as. concentration in the blood and the brain), since this is central to understand the pharmacodynamics (the description of what the drug does to the body and thus the effect it has).
4. 4.to identify biomarkers that can predict whether healthy subjects respond to morphine by experiencing an analgesic effect.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Morphine modulation of composite pain assessments

  october 2010 - december 2012

Secondary Outcomes (1)

• Side effects of morphine

  october 2010 - december 2012

Study Arms (2)

Morphine

EXPERIMENTAL

Drug: Morphine

Placebo

PLACEBO COMPARATOR

Other: orange juice

Interventions

Morphine DRUG

Morphine oral mixture

Also known as: Morphine hydrochloride oral solution 2 mg/ml

Morphine

orange juice OTHER

orange juice

Also known as: orange juice solution

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated "Written informed consent"
• Age between 20 and 65.
• Caucasian
• The person must be healthy ie. without previous chronic or recurrent pain rewarding diseases. Including the person must have:
• a blood pressure is 140/90 or less. If not satisfied, a medical assessment to determine whether the person is still included, albeit with a comment and reasons recorded in the CRF.
• a resting heart rate of at least 45 bpm. minute (measured after 5 minutes of recumbent rest). If not satisfied, a medical assessment to determine whether the person is still included, albeit with a comment and reasons recorded in the CRF.
• That women use safe contraceptive methods as the pill, coil, depot injection of progestin subdermal implantation, hormonal vaginal ring and transdermal patch.
• Negative pregnancy test prior to the conclusion of the experiment

You may not qualify if:

• Pregnancy.
• Known allergy to study medication
• Current or previous participation in another drug trial within 30 days before screening.
• Former participation in trials when given morphine or morphine-like substances.
• Former addiction behaviors defined as abuse of alcohol, marijuana, opiates or other narcotics or family members who have been / are a drug addict.
• Earlier pain rewarding or mental illness.
• Expected need for medical treatment, surgery or hospitalization during the study
• Concomitant use of strong pain medications
• Use of any analgesics 24 hours before each test.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Gastroenterology, Aalborg Hospital

Aalborg, 9000, Denmark

Location

Related Publications (2)

• Hansen TM, Olesen AE, Graversen C, Drewes AM, Frokjaer JB. The Effect of Oral Morphine on Pain-Related Brain Activation - An Experimental Functional Magnetic Resonance Imaging Study. Basic Clin Pharmacol Toxicol. 2015 Nov;117(5):316-22. doi: 10.1111/bcpt.12415. Epub 2015 May 29.

  PMID: 25924691 DERIVED

• Hansen TM, Graversen C, Frokjaer JB, Olesen AE, Valeriani M, Drewes AM. Single-sweep spectral analysis of contact heat evoked potentials: a novel approach to identify altered cortical processing after morphine treatment. Br J Clin Pharmacol. 2015 Jun;79(6):926-36. doi: 10.1111/bcp.12579.

  PMID: 25556985 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Anne E Olesen, PhD

  Aalborg University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: November 22, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 21, 2012

Record last verified: 2012-09

Locations

DK (1)